Rochal Antimicrobial Wound Gel
K-Number: K192527 · 2020-02-07
ApplicantRochal Industries, LLC
Decision Date2020-02-07
Product CodeFRO
DecisionSubstantially Equivalent
Device Summary
Rochal Antimicrobial Wound Gel is a medical device manufactured by Rochal Industries, LLC. It received FDA 510(k) clearance on 2020-02-07 under approval number K192527. The device is classified under product code FRO. Product code FRO falls under the category of Anesthesiology, which includes devices for anesthetic delivery and patient monitoring. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Rochal Antimicrobial Wound Gel?
Rochal Antimicrobial Wound Gel is a medical device that received FDA 510(k) clearance on 2020-02-07. It is manufactured by Rochal Industries, LLC. The 510(k) number is K192527.
When was Rochal Antimicrobial Wound Gel approved by the FDA?
Rochal Antimicrobial Wound Gel received FDA 510(k) clearance on 2020-02-07, under approval number K192527.
What company makes Rochal Antimicrobial Wound Gel?
Rochal Antimicrobial Wound Gel is manufactured by Rochal Industries, LLC.
What is the FDA product code for Rochal Antimicrobial Wound Gel?
The FDA product code for Rochal Antimicrobial Wound Gel is FRO. This falls under the Anesthesiology category.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.